Committee on Market Access - Notification pursuant to the Decision on Notification Procedures for Quantitative Restrictions (G/L/59/Rev.1) - United Kingdom - Addendum
作者:United Kingdom


United Kingdom


The following communication, dated 3 January 2023, is being circulated at the request of the delegation of the United Kingdom.


A.      Notifying Member: United Kingdom

B.      Date of notification: 3 January 2023

C.      First time notification:


      No, last notification was made in (doc. symbol): G/MA/QR/N/GBR/2

D.      Type of notification:

      1.  Complete (i.e. notification of all quantitative restrictions in force)

      2.  Changes to a notification previously made in G/L/59/REV.1 which are of the following nature:

            2.1   Introduction of new restrictions, as listed in Section 1.

            2.2   Elimination of restrictions, as described in G below.

            2.3   Modification of a previously notified restriction, as described in Section 1.

      3.  Reverse notification of restrictions maintained by (Member):

E.     The notification provides information for the following biennial period (e.g. 2012‑2014): 2022-2024 and relates to restrictions in force as of 20 December 2022

F.      This notification contains information* relating to:

      Section 1:   List of quantitative restrictions that are currently in force.

      Section 2:  Cross-reference to other WTO notifications with information on quantitative restrictions that are currently in force and additional information.

G.      Comments of a general nature, including a description of the elimination of restrictions notified under D.2.2 and the date they ceased to be in force.

1.    This addendum modifies and replaces QR No. 21 of G/MA/QR/N/GBR/2. This notification updates the list of commodity codes applicable to the medicines in scope and provides appropriate information on the product descriptions.

2.    The UK is notifying the reduction of 10 medicines from the list of medicines, placed on the UK market, which are subject to limited export restrictions. These medicines no longer meet the tests set to maintain measures. These are: Anakinra, Budesonide, Calcium Chloride, Colestyramine, Dexmedetomidine, Epoprostenol, Milrinone, Rifampicin, Rivaroxaban and Salbutamol. Insulin human has also been removed as this is the same product as insulin soluble human.

3.    The UK is also notifying the addition of 10 medicines to the list in critical short supply, in lieu of other shortage mitigations taking effect.

4.    Amoxicillin, Phenoxymethylpenicillin (Penicillin V), Flucloxacillin (3004.10.00); Cefalexin and Azithromycin (3004.20.00) are antibiotics used in the treatment of Streptococcal A infections. Measures are in place while the Department of Health and Social Care (DHSC) work across the supply chain to bring forward stock and expedite deliveries, ensure antibiotic orders are proportionate, and issue directions to utilise alternative medicines where appropriate.

5.    Alteplase and Tenecteplase (3004.90.00) are used for a number of critical indications including ischaemic stroke, myocardial infarction and pulmonary embolism for which there is no alternative treatment. Oseltamivir and Zanamivir (3004.90.00) are antiviral medicines used to treat and prevent influenza. Semaglutide (3004.90.00) is a critical drug used to treat patients with Type 2 diabetes. Measures are in place while DHSC works with healthcare bodies to ensure continued access to treatment, and while Serious Shortage Protocols (SSPs) take effect, enabling Pharmacists to issue alternative medicines where available to manage shortages.

6.    These are temporary measures, in place to relieve critical shortages of medicines necessary for the protection of human health. Measures are reviewed regularly and only applied where the critical need cannot be met by alternative measures. On 15 December 2021, 47 medicines were removed from the list. On 24 June 2022, a further 30 (net) medicines were removed from the list.

7.    The UK's notification G/MA/QR/N/GBR/2 included details relating to Northern Ireland. This notification does not amend those details which continue to apply






Section 1: List of quantitative restrictions that are currently in force



General description of the restriction

Type of restriction

Tariff line code(s) affected, based on HS (2017)

Detailed Product Description

WTO Justification and Grounds for Restriction, e.g. Other International Commitments

National legal basis and entry into force

Administration, modification of previously notified measures, and other comments









Measures to regulate exports of certain medicaments.


Medicines fall under the following commodity codes:


1. Heading 3002 - Classification

Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products; cell cultures, whether or not modified


Product Description per Commodity Code under Heading 3002

Vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products, Other

Article XX(b) GATT

Protection of human, animal or plant life or health.


Regulation 43(2) of the Human Medicines Regulations 2012 requiring wholesale dealers to ensure continued supply of medicinal products so that the needs of patients in the UK are met. Further details can be found through:


The date restrictions came into effect varies by medicine; this is specified for each medicine on the list, last updated on 20 December 2022 and available on at:


The list of medicines is maintained by the Department of Health and Social Care.


These measures are reviewed regularly.

A full change log of previous measures, from October 2019, can be found here:


Medicines included on this list meet the following conditions:

·        The medicine is required to meet the needs of UK patients

·        The medicine is currently in shortage or risk of being in shortage

·        The export of the medicine would contribute to or exacerbate a shortage, or risk of shortage, of that medicine in the UK







2. Heading 3004 - Classification

Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale

Product Description per Commodity Code under Heading 3004

Containing penicillins or derivatives thereof, with a penicillanic acid

structure, or streptomycins or their derivatives

Other, containing antibiotics

Other, containing hormones or other products of heading 2937, Containing insulin



Medicines on this list which have been produced to fulfil contracts overseas are not subject to restriction. As such, restrictions only apply to wholesaler dealer licence holders that are not the market authorization holder for a medicine intended for export. The measures are designed to ensure wholesalers fulfil their legal obligations to maintain supply to UK patients.


These restrictions are only applied and maintained where alternative measures are not considered sufficient on their own to ensure that UK supply meets demand.


A number of exemptions apply to medicines in scope of these restrictions. For example, exports destined for international humanitarian organizations such as COVAX are not covered. A full list of exemptions can be found at:









Containing corticosteroid hormones, their derivatives or structural analogues

Other, containing hormones or other products of heading 2937, Other

Other, containing alkaloids or derivatives thereof, Other




Requests for exemptions are considered on a case-by-case basis. These can be submitted by a foreign government or government agency, or a wholesaler on their behalf at:


Further information on these measures is available here:






Further detail of these medicines can be found at:

These restrictions apply in certain circumstances to exports of specified medicines which are placed on the UK market for UK patients and needed to protect human health, including to treat COVID-19, inter alia.



It is the responsibility of the wholesaler to ensure any exports are made or withheld in compliance with these restrictions. Failure to comply with these restrictions may lead to regulatory action by the Medicines and Healthcare products Regulatory Authority (MHRA) against the wholesale dealer's licence.

There are no additional steps or declarations required from a customs perspective.


* In English only.